Skeletal Muscle Paralysis in Hypothermic Patients After Cardiac Arrest

NCT ID: NCT01719770

Last Updated: 2015-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2015-04-30

Brief Summary

Mild hypothermia improves neurological outcome after cardiac arrest. Neuromuscular blockers are in use, together with analgesia and sedation, during the cooling process in many centers to prevent shivering. Since neuromuscular blockers are accused to be associated with various side effects causing serious harm and/or leading to prolong ICU stay. So economical use seems to be reasonable. Furthermore, the use of neuromuscular blockers may mask epileptic activity. Therefore, post hypoxic seizures might remain undetected.

Aim of this study is to investigate if a continuous application of neuromuscular blockers is necessary to prevent shivering and thereby avoid the counter regulation to achieve the target temperature as soon as possible in mild hypothermic therapy after cardiac arrest.

A single center (university hospital) study. Randomized, double blinded, double dummy study design. Eligible are all adult patients after successful resuscitation due to cardiac arrest of presumed cardiac origin.

All patients receiving mild therapeutic hypothermia after cardiac arrest of presumed cardiopulmonary origin will be included.

Patients <18 years, cardiac arrest >6 hours before admittance at the hospital, patients with known or clinically apparent pregnancy, patients who reach our hospital with a body temperature below 35°C, patients with known allergic reactions against rocuronium, patients with a history of myasthenia gravis, patients with obvious intoxication, wards of the state/prisoners and patients with known epileptic disease will be excluded.

Primary outcome:

Shivering episodes will be scored with the Shivering Assessment Scale.

Secondary outcome:

Total doses of rocuronium, time to target core temperature of 33°C, dissipated energy and total energy needed during the cooling period will be compared between the two groups.

Changes in basal metabolism and depth of relaxation will be ascertained. Furthermore, serum levels of midazolam, fentanyl, rocuronium and stress hormones will be measured.

Train-of-four will be performed to assess the depth of relaxation. Sedation will be monitored via bispectral index; measurement of metabolic activity will be evaluated using indirect calorimetry. Additionally, EEG will be performed to detect epileptiform activities. Blood will be drawn to measure levels of midazolam, fentanyl and rocuronium.

Conditions

Cardiac Arrest With Successful Resuscitation; Hypothermia; Skeletal Muscle Relaxant Overdose

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rocuronium

Continuous infusion of rocuronium with 0,25mg/kg (blinded) for 29 hours after initiation of mild therapeutic hypothermia

Group Type: ACTIVE_COMPARATOR

rocuronium

Intervention Type: DRUG

continuous application of rocuronium 0,25mg/kg/h (blinded), in case of shivering episode bolus sodium-chloride (blinded)

Placebo

Continuous infusion of sodium-chloride (placebo) and rocuronium bolus (0,25mg/kg)in case of shivering episode (blinded)

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

continuous infusion of sodium-chloride (blinded), in case of shivering episode application of rocuronium 0,25mg/kg (blinded)

Interventions

rocuronium

continuous application of rocuronium 0,25mg/kg/h (blinded), in case of shivering episode bolus sodium-chloride (blinded)

Intervention Type: DRUG

placebo

continuous infusion of sodium-chloride (blinded), in case of shivering episode application of rocuronium 0,25mg/kg (blinded)

Intervention Type: OTHER

Other Intervention Names

Esmeron; sodium-chloride

Eligibility Criteria

Inclusion Criteria

• all patients receiving mild therapeutic hypothermia after cardiac arrest
• cardiac arrest due to cardiopulmonary origin

Exclusion Criteria

• patients younger than 18 years
• traumatic cardiac arrest
• cardiac arrest due to exsanguination, strangulation, smoke inhalation, drug overdose, electrocution, hanging or drowning
• known or clinically apparent pregnancy
• no treatment with mild therapeutic hypothermia because of an AND order
• terminal illness
• a body core temperature below 35°C at hospital admission
• known allergic reaction against rocuronium
• history of myasthenia gravis
• obvious intoxication
• ward of the state or prisoner
• known epileptic disease
• cardiac arrest >6 hours prior to hospital admission

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Heidrun Losert

Priv. Doz. Dr. Heidrun Losert

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heidrun Losert, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna, Department of Emergency Medicine

Locations

Medical University of Vienna, Department of Emergency Medicine

Vienna, Vienna, Austria

Countries

Austria

Other Identifiers

RELAX1

Identifier Type: -

Identifier Source: org_study_id